A Pfizer NDA seeking traditional approval for its Covid-19 drug Paxlovid (nirmatrelvir and ritonavir co-packaged tablets) heads to a 3/16 Antimicrobia...
FDA posts a draft guidance on wet age-related macular degeneration drug development.
FDA commissioner Robert Califf calls for better evidence generation and suggests that with the rapidly advancing artificial intelligence (AI) space (e...
Attorney Jeffrey Shapiro says FDA is using a new draft guidance to significantly expand the instances when human factors data must be part of a 510(k)...
Octapharma USA submits an sBLA for an expanded indication for its Wilate von Willebrand disease bleeding control drug.
PhRMA gives FDA specific comments and edits on the International Council for Harmonization M11 protocol. Template, and technical specification.
The Centers for Medicare & Medicaid Services says it is not reconsidering its national coverage determination that restricts Medicare coverage on Alzh...
University of Pennsylvania researchers call on FDA to act more quickly when accelerated approval cancer drugs fail confirmatory tests to cut the time ...
